Medical Reviewer – Pharmacovigilance & Drug Safety
Location: [Not Specified]
Experience: 3+ years
Job Type: Full-Time
Job Overview:
We are currently seeking a Medical Reviewer to join our growing Pharmacovigilance team. This role is integral to the review and medical assessment of Individual Case Safety Reports (ICSRs) from various sources such as clinical trials, spontaneous, and solicited reports. You will ensure compliance with pharmacovigilance regulations and contribute to aggregate safety reporting, risk management planning, and signal detection for a wide therapeutic portfolio.
Key Responsibilities:
Medical Review & Case Assessment:
Perform medical review of ICSRs, ensuring proper triage, seriousness determination, and relatedness assessment
Verify AE selection, MedDRA coding, labeling compliance, and narrative accuracy
Assess case reportability for regulatory submission and ensure timely case processing
Support litigation case assessments and escalate complex cases as needed
Communicate and coordinate effectively with client therapeutic teams and safety physicians
Safety Strategy & Signal Detection:
Contribute to safety surveillance strategies and signal management plans
Conduct medical review and support for signal detection and evaluation activities
Prepare and review aggregate safety documents including PADERs, DSURs, RMPs, and Signal reports
Participate in the preparation and maintenance of Company Core Data Sheets (CCDS)
Collaboration & Mentorship:
Serve as a subject matter expert (SME) for therapeutic areas/products
Mentor and guide junior medical reviewers and contribute to continuous learning
Collaborate with cross-functional teams and escalate site-level or case-specific issues as required
Process & Quality Compliance:
Adhere to pharmacovigilance regulations (e.g., ICH, GVP) and SOPs
Perform follow-ups on outstanding site queries and data discrepancies
Maintain high levels of accuracy, consistency, and regulatory compliance in documentation
Candidate Profile:
Education: Degree in Medicine (MBBS/MD or equivalent) or advanced life science qualification with clinical experience
Experience:
3+ years in pharmacovigilance or clinical research medical review
Proficiency in ICSR handling and regulatory safety reporting
Familiarity with pharmacovigilance databases (e.g., ARGUS, ArisG)
Technical Knowledge:
Understanding of GCP, GVP, MedDRA, ICH guidelines, and regulatory safety obligations
Competence in literature review and analysis for safety assessment
Soft Skills:
Strong communication and interpersonal skills
Ability to work independently and in a team
Structured, detail-oriented, and capable of multitasking under tight timelines
Tools:
Proficiency in MS Office Suite (Word, Excel, PowerPoint)
Experience with safety databases and document management systems
Estimated Salary: ₹10 – ₹16 LPA (depending on qualifications and experience)
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